Quick Facts at a Glance
- Recall Date
- September 18, 2025
- Hazard Level
- HIGH
- Brand
- Cardinal Health 200
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Cardinal Health 200
- Product type
- Salem Sump Silicone Dual-Lumen Stomach Tube
- Model numbers
- 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, 8888265116 Salem Sump Silicone Dual Lumen Stomach Tube, 8888265124 Salem Sump Silicone Dual Lumen Stomach Tube, 8888265132 Salem Sump Silicone Dual Lumen Stomach Tube, 8888265140 Salem Sump Silicone Dual Lumen Stomach Tube, 8888266213 Salem Sump TM Silicone Dual Lumen Stomach Tube, 8888266221 Salem Sump TM Silicone Dual Lumen Stomach Tube, 8888266247 Salem Sump TM Silicone Dual Lumen Stomach Tube +2 more
- Sizes
- 10 Fr (3.3 mm) x 36 in (91 cm), 12 Fr (4.0 mm) x 48 in (122 cm), 14 Fr (4.7 mm) x 48 in (122 cm), 16 Fr (5.3 mm) x 48 in (122 cm), 18 Fr (6.0 mm) x 48 in (122 cm) +5 more
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 18, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cardinal Health 200, LLC or your healthcare provider for instructions. Notification method: Letter
About This Product
Salem Sump tubes are medical devices used for gastric decompression in clinical settings. They come in multiple sizes and configurations for radiopaque visualization and ARV variants.
Why This Is Dangerous
Excessive force can cause Anti-Reflux Valve breakage, potentially compromising tube function and patient safety.
Industry Context
This recall is not described as part of a broader industry pattern in the provided notice.
Real-World Impact
Immediate halt of device use is required in clinical settings to prevent potential device malfunction or patient harm.
Practical Guidance
How to identify if yours is affected
- 1. Compare your tube's product code to the listed 8888265108–8888266288 range and any ARV variants.
- 2. Verify Fr size and length against the sizes shown in the recall data.
- 3. Inspect for any signs of ARV damage or valve instability.
Where to find product info
Inspect packaging and device labeling for product codes and ARV configurations. Official identifiers may appear on the tube or box.
What timeline to expect
4-8 weeks for refund or replacement processing once initiated.
If the manufacturer is unresponsive
- Document all communications with the supplier.
- Escalate to hospital administration or regulatory body if no response within 2–4 weeks.
How to prevent similar issues
- Verify ARV design and compatibility with clinical procedures before ordering.
- Follow manufacturer usage guidance to minimize stress on valves.
- Maintain a log of recalled devices and replace per instructions with safer alternatives.
Documentation advice
Keep all receipts, correspondences, and photos of affected devices and labels for records.
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Product Details
Product codes/names include 8888265108 to 8888265140 for Salem Sump silicone dual-lumen tubes with radiopaque lines, and 8888266213 to 8888266288 for Salem Sump TM variants with anti-reflux valves. Sizes range from 10 Fr to 18 Fr with lengths up to 48 in (122 cm). Products listed also include radiopaque-line versions and anti-reflux valve versions. Distribution is worldwide, including U.S. nationwide and numerous international markets.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution including US nationwide and many countries
- 10–18 Fr sizes; radiopaque line versions and anti-reflux valve variants
- All lots included in the recall
- Recall date 2025-09-18; report date 2025-10-29
- High-risk ARV breakage hazard with potential patient harm
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Safety Guide
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